Cognitive Behavioral Therapy for Insomnia (CBTI) in GERD Patients With Insomnia

Single-arm Pilot Trial of Web-based Cognitive Behavioral Therapy for Insomnia (CBTI) in Gastroesophageal Reflux Disease (GERD) Patients With Insomnia

This study will enroll patients with persistent reflux symptoms despite proton-pump inhibitor therapy and chronic insomnia. Participants that are eligible for the study and agree to participate will receive cognitive behavioral therapy for insomnia (CBTI) delivered by a web-based approach. The goal of the treatment is to improve the participants insomnia and reflux symptoms. In addition to the cognitive behavioral therapy, participants will be asked to keep a daily diary and periodically complete questionnaires to assess their symptoms.

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Behavioral: Web-based CBTI

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan GI Physiology Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with persistent reflux symptoms (GERDQ >8) despite proton-pump inhibitor (PPI) therapy.
• Patients screened positive for chronic insomnia (insomnia severity index [ISI] ≥15).

Exclusion Criteria:

• Patients with major esophageal motility disorder, prior foregut surgeries, severe cardiopulmonary diseases, or major psychological comorbidities.
• Patients who report being in "poor" or "very poor" physical or mental health.
• Patients with sleep apnea (based on STOP-BANG questionnaire >4)
• Patients with AUDIT score >15, indicating alcohol dependence
• Patients regularly taking medications for sleep >2 times per week who cannot stop the sleep aid at least 4 weeks prior to and during the study trial.
• Patients who have previously undergone CBT for insomnia (in person or online).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Web-based CBTI; Participants will have 8 weeks to receive 6 therapy sessions. Content is dynamically driven by an animated therapist who guides the user through the program.	Behavioral: Web-based CBTI; Sessions comprise a range of cognitive and behavioral techniques and psychoeducation including sleep hygiene. During the intervention period the participant will complete daily online sleep diaries. Additionally, participants will be asked to complete multiple questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reflux Symptom Questionnaire-7-day recall (RESQ-7)	RESQ-7 contains 13 items which are aggregated to 4 frequency and 4 intensity domain scores: heartburn (5 items), regurgitation (4 items), cough, hoarseness, difficulty swallowing (3 items), burping (1 item). Frequency questions are scored from 0-7 and intensity questions are scored from 0-5. The range of scores are 0-156 (0 meaning no symptoms, 156 being the worst).	up to 8 weeks post treatment
Gastroesophageal Reflux Disease Quality of Life (GERD-QoL)	The questionnaire is composed of 6 items, 4 of which assess symptoms and situations considered positive predictors for GERD diagnosis: heartburn, regurgitations, disorders related to sleep and use of over the counter products. Other 2 items assess 2 nausea and epigastric pain. Participants answer each question about symptoms frequency during last week using a Likert like scale from 0 to 3 for positive predictors and from 3 to 0 for negative predictors. The maximum score that can be obtained is 18.	up to 8 weeks post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia severity index (ISI)	ISI is a 7-item psychometrically validated measure used to rate insomnia.The total score ranges from 0-28 where higher values indicate increased severity of insomnia.	up to 8 weeks post treatment
Sleep Onset Latency (SOL)	This is based on the participants sleep diary and how many minutes it took the participants to fall asleep.	up to 8 weeks post treatment
Wake After Sleep Onset (WASO)	This is based on the participants sleep diary and how many minutes they woke up after sleeping.	up to 8 weeks post treatment

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: American Gastroenterological Association
• Investigators: Principal Investigator: Joan Chen, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2019
• Primary Completion (ACTUAL): March 25, 2022
• Study Completion (ACTUAL): March 25, 2022

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (ACTUAL): April 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: GERD; cognitive behavioral therapy
• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Sleep Initiation and Maintenance Disorders; Gastroesophageal Reflux
• Other Study ID Numbers: HUM00157452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No